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After the August 12 dismissal of a lawsuit that has stymied distribution of key mouse models, Alzheimer’s disease researchers can breathe a sigh of relief. However, some may still be holding their breath as other allegations of similar patent infringement continue wending their way through the courts, and new ones have cropped up.

In February 2010, the Alzheimer’s Institute of America, Inc. (AIA) of Kansas City, Kansas, sued eight parties on claims that they infringed on patents covering the Swedish mutation of the amyloid precursor protein (APPswe), which causes early onset AD (for extensive background on the case and AIA, see ARF related news story). Outraging some scientists, the defendants—among them Elan, Eli Lilly, and smaller companies—also included The Jackson Laboratory, a nonprofit research institute in Bar Harbor, Maine, that maintains and distributes 22 APPswe transgenic mouse strains as a service to the research community at large.

Already beset by other patent litigation that has made researchers wary about submitting mice to its AD repository, The Jackson Laboratory suffered further from AIA’s recent action. After the suit was filed, “one institution asked us to stop distributing their model,” JAX house counsel David Einhorn told ARF. “In other cases, institutions did not want to send us mice.”

The lawsuit came to a head when AIA asked The Jackson Laboratory (JAX) to disclose the names of researchers who had received mice from its AD collection. “We were not willing to provide that,” said geneticist Mike Sasner, who manages the JAX AD repository, which has distributed tens of thousands of mice to labs worldwide since 2003. “We knew [AIA] was prepared to sue those researchers if any developments came as a result of their using the mice. At that point, we realized we needed somebody to intervene, and that the government had an interest in doing this.”

In December, Einhorn wrote to the U.S. National Institutes of Health (NIH) noting that the mice at issue had been developed by academic labs receiving NIH support and distributed to academics funded by NIH. The Jackson Laboratory also receives NIH funding. “My point was that the NIH was involved in every step—funding the models, funding their distribution, funding the use of the models,” Einhorn said.

The NIH agreed, and took action. In June, Director Francis Collins wrote a letter to The Jackson Laboratory that affirmed the importance of its AD model repository and granted the NIH’s “authorization and consent” to continue maintaining and distributing AD mice with the APP Swedish mutation. A key consequence of this intervention was that AIA would need to sue the NIH with a separate lawsuit in Washington, DC, if it wanted to continue pressing charges against JAX.

On August 9, in a move heralded by the NIH as “a victory for access to research resources,” AIA agreed to dismiss its case against The Jackson Laboratory.

“This is wonderful news,” David Holtzman of Washington University School of Medicine in St. Louis, Missouri, wrote in an e-mail to ARF. “The mice distributed by The Jackson Laboratory have made a major contribution in allowing investigators all over the world to make fundamental basic and disease-related insights into Alzheimer’s disease. This type of effort should only get to be a bigger, not smaller, enterprise until we have solved this disease.”

Of the six parties named alongside JAX in the lawsuit filed and amended in early 2010, only Elan and Eli Lilly remain. The other companies—AnaSpec, Inc., Fremont, California; Immuno-Biological Laboratories, Inc., Minneapolis, Minnesota; Phoenix Pharmaceuticals, Inc., Burlingame, California; and American Peptide Company, Inc., Sunnyvale, California—have settled, AIA attorney Lee Marshall noted in an e-mail to ARF.

But other AIA lawsuits alleging APPswe patent infringement continue to plod along. For example, in the summer of 2009, AIA brought a suit against Oklahoma Medical Research Foundation (OMRF), Oklahoma City, and the biotech company CoMentis of South San Francisco. Two years later, this case is stuck in a pre-trial phase known as discovery. OMRF counsel Adam Cohen noted in an e-mail to ARF that the parties are waiting for the court to schedule a special hearing in which they will wrangle over key patent terms—among them “isolated” and “isolated cell,” “nucleic acid encoding human amyloid precursor protein,” and “fragment.” Only after this hearing has taken place and the court renders its opinion on the disputed terms can the case move to trial, Cohen said. The median time from filing to trial for a patent case in 2009 was approximately two and a half years, according to a recent PriceWaterhouseCoopers study.

AIA’s latest charge, filed in November 2010, aims at Avid Radiopharmaceuticals and the University of Pennsylvania, both in Philadelphia, based on their commercial collaboration and development of the amyloid imaging agent florbetapir. Their research used several transgenic strains (Tg2576 and APPswe-PSEN1) covered by AIA patents (5,455,169 and 7,538,258) and led to Eli Lilly’s acquisition of Avid in a deal valued up to $800 million, Marshall noted.

At the request of the judge, the two sides presented oral arguments August 10 on two key issues concerning the named patents, both owned by Michael Mullan of the Roskamp Institute in Sarasota, Florida. One issue is inventorship. “AIA says Mullan is the only inventor of the inventions claimed in the patents being asserted. Penn and Avid disagree,” Penn counsel Robert Firestone told ARF. “We think there may be co-inventors on one or more of those patents.” The second issue is ownership—i.e., did Mullan himself own the rights he purported to assign to AIA, or did the institutions at which he did his research have ownership rights?

As for when a decision may be expected, “federal judges govern their own calendar,” Firestone quipped. “It could be weeks. It could be days. It could be months. I would be very surprised if it’s years. I think it will be weeks.”

More important than timing, perhaps, is the outcome. “If the judge rules in favor of AIA, then the case will continue. If the judge denies both parties’ motions, then the case also continues,” Firestone said. “But if the judge rules in favor of Penn and Avid on either the inventorship or ownership issue, the case should be dismissed.”—Esther Landhuis.

Comments

The Jackson Laboratory is an invaluable resource for the AD research community. The current climate of fear can only be harmful to the future patients who will so desperately need the end products of this research. In an ideal world, some sort of ethical arbitration (with future patients recognized as stakeholders) could be implemented, rather than these lengthy, costly court actions.